#SystematicLiteratureReview #SLR #MDR #PostMarketSurveillance #PMLS
Joining Criterion Edge's President Laurie Mitchell, is guest speaker, Queenita Fernandes, Medtronic's Medical Safety Manager, Patient Monitoring & Respiratory Interventions. In this webinar, you will learn how to deploy systematic literature review in order to augment post market clinical surveillance, and our best tips on a robust systematic literature review process. Following this, our guest speaker shares an informative case study illustrating more.
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///Key Takeaways///
• How to leverage published data to meet regulatory expectations and inform internal decision-making
• Steps for conducting a methodologically-sound SLR
• How data obtained through SLR can empower the successful execution of post-market surveillance activities, drive efficiencies, and support regulatory compliance.
///Who Should Watch///
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.
///Speaker///
Laurie Mitchell
Founder/President of Criterion Edge, a global regulatory writing services firm serving the medical device, pharmaceutical, and biotech industries. She has over 25 years experience in medical writing, pharmacovigilance management, and regulatory reporting. Prior to Criterion Edge, Laurie founded Mitchell Research Group, a successful site management organization, and acted as a Clinical Safety consultant for Abbott Vascular for almost a decade. Laurie brings extensive experience creating and training Data Safety Monitoring Boards and Clinical Event Committees and working with global cross-functional teams. Having worked for three of the four major medical device sponsors, she maintains expertise in many therapeutic areas. She holds a BS in Nursing and an MS as a Cardiopulmonary Clinical Nurse Specialist from UCLA.
Queenita Fernandes
Queenita Fernandes graduated with a Medical Degree in wholistic medicine from the Maharashtra State University, India and is a Certified Healthcare Practitioner & Patient Safety Professional. She has been working with Medtronic for 8 years in different roles and capacities. Her expertise includes medical and regulatory writing, promotional writing, complaint handling, and research to name a few. In her current role as Medical Safety Manager, she and her team focus on post-market literature surveillance in a proactive effort to identify patient safety events.
Негізгі бет Ғылым және технология Post-Market Literature Surveillance: Systematic Literature Review and Case Study
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